[18F]Fluciclatide-PET, Pazopanib and Paclitaxel in Ovarian Cancer - Full Text View

Purpose

The purpose of this study is to assess [18F] -fluciclatide as a biomarker of response to pazopanib and to evaluate the efficacy and safety of the combination of pazopanib and paclitaxel in platinum-resistant ovarian cancer patients.

Condition	Intervention	Phase
Ovarian Neoplasm	Drug: Pazopanib and paclitaxel	Phase 1


Study Type:	Interventional
Study Design:	Intervention Model: Single Group Assignment Masking: None (Open Label) Primary Purpose: Treatment
Official Title:	Phase 1b Exploratory Study of [18F]Fluciclatide-PET as a Marker of Angiogenic Response to Combination Therapy With the Pan-VEGF Inhibitor, Pazopanib, and Weekly Paclitaxel in Platinum Resistant Ovarian Cancer

Resource links provided by NLM:

Genetics Home Reference related topics: ovarian cancer

MedlinePlus related topics: Ovarian Cancer

Drug Information available for: Paclitaxel Pazopanib

Genetic and Rare Diseases Information Center resources: Ovarian Cancer

U.S. FDA Resources

Further study details as provided by Imperial College London:

Primary Outcome Measures:

Assessment of change in [18F]-fluciclatide retention parameters following 1 week of pazopanib treatment [ Time Frame: 1 week ]
Semi-quantitative standardized uptake value and fully quantitative net irreversible plasma to tumour transfer constant

Secondary Outcome Measures:

The proportion of women who experience side effects from the combination of paclitaxel and pazopanib [ Time Frame: 12 months ]
Core study assessments including physical examination, vital signs, ECG, and adverse event reporting
The proportion of patients responding to combination paclitaxel and pazopanib [ Time Frame: 12 months ]


Enrollment:	16
Study Start Date:	July 2012
Study Completion Date:	April 2016
Primary Completion Date:	May 2015 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Pazopanib and paclitaxel	Drug: Pazopanib and paclitaxel Pazopanib 800mg od for 7 days, followed by 18 weeks of combination therapy (paclitaxel 80mg/m2 weekly and pazopanib 800mg od). Following the completion of combination therapy, patients will continue on maintenance pazopanib 800mg od until disease progression.

Eligibility


Ages Eligible for Study:	18 Years and older (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

Age ≥ 18 years
Diagnosis of relapsed ovarian cancer
Responded to at least on one line of prior platinum based therapy
Relapsed within platinum resistant interval (≤6months)
Eastern Cooperative Oncology Group (ECOG) performance status of <2
Measurable disease defined as a lesion that can be accurately measured in at least one dimension with the longest diameter ≥25mm using conventional techniques
Satisfactory baseline haematologic and organ function:
- Haematologic: Absolute neutrophil count > or = 1.5 X 10^9/L; Platelets > or = 100 X 10^9/L; Haemoglobin > or = 9g/dL; PT or INR < or = 1.2 x ULN; PTT < or = 1.2 x ULN
- Hepatic: Bilirubin < or = 1.5 X ULN; AST or ALT < or = 2.5 X ULN
- Renal: Serum creatinine < or = 1.5 mg/dL; Or if >1.5 mg/dL, calculated creatinine clearance > or = 50mL/min; UPC <1

Exclusion Criteria:

Poorly controlled hypertension [defined as systolic blood pressure (SBP) of ≥140 mmHg or diastolic blood pressure (DBP) of ≥ 90mmHg]. Note: Initiation or adjustment of antihypertensive medication(s) is permitted prior to study entry. BP must be re-assessed on two occasions that are separated by a minimum of 1 hour; on each of these occasions, the mean (of 3 readings) SBP / DBP values from each BP assessment must be <140/90 mmHg in order for a subject to be eligible for the study.
Treatment with any of the following anti-cancer therapies:
- radiation therapy 28 days prior to the first dose of pazopanib OR
- surgery or tumor embolization within 14 days prior to the first dose of pazopanib OR
- chemotherapy, immunotherapy, biologic therapy, investigational therapy or hormonal therapy within 14 days or five half-lives of a drug (whichever is longer) prior to the first dose of pazopanib
Treatment with anti-angiogenic therapy
Presence of gross ascites
Clinically significant peripheral neuropathy
Females of childbearing potential who are unwilling to avoid pregnancy, for the duration of the study

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01608009

Locations


United Kingdom
Imperial College Healthcare NHS Trust
London, United Kingdom
Southend University Hospital NHS Foundation Trust
Southend, United Kingdom

Sponsors and Collaborators

Imperial College London

GlaxoSmithKline

Investigators


Study Director:	Rohini Sharma, MD	Imperial College London
Principal Investigator:	Timothy Crook, MD	Southend University Hospital NHS Foundation Trust

More Information


Responsible Party:	Imperial College London
ClinicalTrials.gov Identifier:	NCT01608009 History of Changes
Other Study ID Numbers:	CRO1627
Study First Received:	March 22, 2012
Last Updated:	March 9, 2017

Keywords provided by Imperial College London:


platinum resistant ovarian cancer

Additional relevant MeSH terms:


Ovarian Neoplasms Endocrine Gland Neoplasms Neoplasms by Site Neoplasms Ovarian Diseases Adnexal Diseases Genital Diseases, Female Genital Neoplasms, Female Urogenital Neoplasms Endocrine System Diseases	Gonadal Disorders Paclitaxel Albumin-Bound Paclitaxel Antineoplastic Agents, Phytogenic Antineoplastic Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on August 23, 2017

[18F]Fluciclatide-PET, Pazopanib and Paclitaxel in Ovarian Cancer (PAZPET-1)